Chronic edema of the lower extremities: international consensus recommendations for compression therapy clinical research trials.

Chronic edema is a multifactorial condition affecting patients with various diseases. Although the pathophysiology of edema varies, compression therapy is a basic tenant of treatment, vital to reducing swelling. Clinical trials are disparate or lacking regarding specific protocols and application recommendations for compression materials and methodology to enable optimal efficacy. Compression therapy is a basic treatment modality for chronic leg edema; however, the evidence base for the optimal application, duration and intensity of compression therapy is lacking. The aim of this document was to present the proceedings of a day-long international expert consensus group meeting that examined the current state of the science for the use of compression therapy in chronic edema. An expert consensus group met in Brighton, UK, in March 2010 to examine the current state of the science for compression therapy in chronic edema of the lower extremities. Panel discussions and open space discussions examined the current literature, clinical practice patterns, common materials and emerging technologies for the management of chronic edema. This document outlines a proposed clinical research agenda focusing on compression therapy in chronic edema. Future trials comparing different compression devices, materials, pressures and parameters for application are needed to enhance the evidence base for optimal chronic oedema management. Important outcomes measures and methods of pressure and oedema quantification are outlined. Future trials are encouraged to optimize compression therapy in chronic edema of the lower extremities.

[1]  E. A. Nelson,et al.  Intermittent pneumatic compression for treating venous leg ulcers. , 2014, The Cochrane database of systematic reviews.

[2]  A. Szuba,et al.  Clinical trials needed to evaluate compression therapy in breast cancer related lymphedema (BCRL). Proposals from an expert group. , 2010, International angiology : a journal of the International Union of Angiology.

[3]  K. Krleza-Jeric,et al.  CONSORT 2010 , 2010, The Lancet.

[4]  J. Levick,et al.  Microvascular fluid exchange and the revised Starling principle. , 2010, Cardiovascular research.

[5]  K. Alitalo,et al.  Dermal collagen and lipid deposition correlate with tissue swelling and hydraulic conductivity in murine primary lymphedema. , 2010, The American journal of pathology.

[6]  S. Belczak,et al.  Is the wearing of elastic stockings for half a day as effective as wearing them for the entire day? , 2010, The British journal of dermatology.

[7]  C. Moffatt,et al.  Venous leg ulcers: patient concordance with compression therapy and its impact on healing and prevention of recurrence , 2009, International wound journal.

[8]  A. Bouvier,et al.  Prognostic Factors in Stage D Heart Failure in the Very Elderly , 2009, Gerontology.

[9]  Marcella Sarzotti-Kelsoe,et al.  Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I–III Clinical Trials , 2009, PLoS medicine.

[10]  W. Marston,et al.  Inflammatory cytokine levels in chronic venous insufficiency ulcer tissue before and after compression therapy. , 2009, Journal of vascular surgery.

[11]  C. Cimminiello,et al.  Attitudes to prescribing compression stockings for patients with acute dvt: the MASTER registry , 2009, Journal of Thrombosis and Thrombolysis.

[12]  H. Partsch,et al.  Inelastic compression increases venous ejection fraction more than elastic bandages in patients with superficial venous reflux , 2008, Phlebology.

[13]  T. Defloor,et al.  Guidelines for the management of venous leg ulcers: a gap analysis. , 2008, Journal of evaluation in clinical practice.

[14]  H. Córdova,et al.  Congestive heart failure and renal complications. , 2008, Boletin de la Asociacion Medica de Puerto Rico.

[15]  L. Gerber,et al.  Preoperative assessment enables the early diagnosis and successful treatment of lymphedema , 2008, Cancer.

[16]  H. Partsch Intermittent pneumatic compression in immobile patients , 2008, International wound journal.

[17]  H. Partsch,et al.  Controlled, Comparative Study of Relation between Volume Changes and Interface Pressure under Short‐Stretch Bandages in Leg Lymphedema Patients , 2008, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[18]  H Partsch,et al.  Indications for compression therapy in venous and lymphatic disease consensus based on experimental data and scientific evidence. Under the auspices of the IUP. , 2008, International angiology : a journal of the International Union of Angiology.

[19]  R. Schilsky,et al.  American Society of Clinical Oncology Statement on minimum standards and exemplary attributes of clinical trial sites. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[20]  H. Partsch,et al.  Influence of Different Materials in Multicomponent Bandages on Pressure and Stiffness of the Final Bandage , 2008, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[21]  M. Clark,et al.  Classification of Compression Bandages: Practical Aspects , 2008, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[22]  W. Olszewski Contractility Patterns of Human Leg Lymphatics in Various Stages of Obstructive Lymphedema , 2008, Annals of the New York Academy of Sciences.

[23]  J. Tsauo,et al.  Reliability Study of Measurements for Lymphedema in Breast Cancer Patients , 2008, American journal of physical medicine & rehabilitation.

[24]  Melissa J Hagan,et al.  A randomised crossover study of low‐ankle‐pressure graduated‐compression tights in reducing flight‐induced ankle oedema , 2008, The Medical journal of Australia.

[25]  Y P Huang,et al.  High frequency ultrasound assessment of skin fibrosis: clinical results. , 2007, Ultrasound in medicine & biology.

[26]  A. G. Warren,et al.  The Use of Bioimpedance Analysis to Evaluate Lymphedema , 2007, Annals of plastic surgery.

[27]  A. Giannoukas,et al.  Intermittent pneumatic compression (IPC) in the treatment of peripheral arterial occlusive disease (PAOD)--A useful tool or just another device? , 2007, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[28]  Stefan Kubik,et al.  Foldi's Textbook of Lymphology: For Physicians and Lymphedema Therapists , 2007 .

[29]  S. Engelborghs,et al.  Volumetric evaluation of upper extremities in 250 healthy persons , 2007, Clinical physiology and functional imaging.

[30]  W. Hop,et al.  Validation of the inverse water volumetry method: a new gold standard for arm volume measurements , 2006, Breast Cancer Research and Treatment.

[31]  John Boyages,et al.  Reliability and validity of arm volume measurements for assessment of lymphedema. , 2006, Physical therapy.

[32]  M. Clark,et al.  Measurement of Lower Leg Compression In Vivo: Recommendations for the Performance of Measurements of Interface Pressure and Stiffness , 2006, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[33]  V. Preedy,et al.  Scottish Intercollegiate Guidelines Network , 2010 .

[34]  H. Brorson,et al.  Tissue tonometry before and after liposuction of arm lymphedema following breast cancer. , 2005, Lymphatic research and biology.

[35]  M. Augustin,et al.  Development, validation and clinical use of the FLQA-I, a disease-specific quality of life questionnaire for patients with lymphedema. , 2005, VASA. Zeitschrift fur Gefasskrankheiten.

[36]  J. Levick,et al.  Chronic peripheral oedema: the critical role of the lymphatic system. , 2004, Clinical medicine.

[37]  H. Partsch,et al.  Immediate mobilisation in acute vein thrombosis reduces post-thrombotic syndrome. , 2004, International angiology : a journal of the International Union of Angiology.

[38]  V. Chib,et al.  Quantifying Fibrosis in Venous Disease: Mechanical Properties of Lipodermatosclerotic and Healthy Tissue , 2004, Advances in skin & wound care.

[39]  J. Brown A clinically useful method for evaluating lymphedema. , 2004, Clinical journal of oncology nursing.

[40]  M. Prins,et al.  Compression therapy for treating stage I and II (Widmer) post-thrombotic syndrome. , 2003, The Cochrane database of systematic reviews.

[41]  N Bosanquet,et al.  Lymphoedema: an underestimated health problem. , 2003, QJM : monthly journal of the Association of Physicians.

[42]  M. Prins,et al.  Non-pharmaceutical measures for prevention of post-thrombotic syndrome. , 2003, The Cochrane database of systematic reviews.

[43]  C. N. Coleman,et al.  CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. , 2003, Seminars in radiation oncology.

[44]  D. Zarin,et al.  A systematic review of pneumatic compression for treatment of chronic venous insufficiency and venous ulcers. , 2003, Journal of vascular surgery.

[45]  T. Worrell,et al.  Concurrent validity of upper-extremity volume estimates: comparison of calculated volume derived from girth measurements and water displacement volume. , 2003, Physical therapy.

[46]  Antoinette P Sander,et al.  Upper-extremity volume measurements in women with lymphedema: a comparison of measurements obtained via water displacement with geometrically determined volume. , 2002, Physical therapy.

[47]  W. Joyce,et al.  A reduction in serum cytokine levels parallels healing of venous ulcers in patients undergoing compression therapy. , 2002, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[48]  C. Hirst,et al.  A New Technique for the Quantification of Peripheral Edema with Application in Both Unilateral and Bilateral Cases , 2002, Angiology.

[49]  S R Harris,et al.  Measurement of upper extremity volume in women after axillary dissection for breast cancer. , 2001, Archives of physical medicine and rehabilitation.

[50]  M. Maylor Accurate selection of compression and antiembolic hosiery. , 2001, British journal of nursing.

[51]  L C Ward,et al.  Early diagnosis of lymphedema using multiple frequency bioimpedance. , 2001, Lymphology.

[52]  E. Földi,et al.  Effect of complex decongestive physiotherapy on gene expression for the inflammatory response in peripheral lymphedema. , 2000, Lymphology.

[53]  M. Witte,et al.  Diagnostic and interventional imaging of lymphatic disorders. , 1999, International angiology : a journal of the International Union of Angiology.

[54]  Liu Nf,et al.  The role of magnetic resonance imaging in diagnosis of peripheral lymphatic disorders , 1998 .

[55]  P. Mortimer,et al.  Validation of an optoelectronic limb volumeter (Perometer). , 1997, Lymphology.

[56]  M. Aslam,et al.  Infrared optoelectronic volumetry, the ideal way to measure limb volume. , 1996, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[57]  C. Bombardier,et al.  Development of an upper extremity outcome measure: The DASH (disabilities of the arm, shoulder, and head) , 1996 .

[58]  P. Mortimer Evaluation of lymphatic function: abnormal lymph drainage in venous disease. , 1995, International angiology : a journal of the International Union of Angiology.

[59]  J. Casley‐Smith The pathophysiology of lymphedema and the action of benzo-pyrones in reducing it. , 1988, Lymphology.

[60]  E. Vicaut,et al.  [Digital simulation of venous and lymphatic edema and the effects of compression]. , 2011, Journal des maladies vasculaires.

[61]  L. Weisberg,et al.  Fluid accumulation, survival and recovery of kidney function in critically ill patients with acute kidney injury , 2010 .

[62]  S. Vignes,et al.  [Adverse effects of compression in treatment of limb lymphedema]. , 2009, Journal des maladies vasculaires.

[63]  K. Seers,et al.  WITHDRAWN: Antibiotics / anti-inflammatories for reducing acute inflammatory episodes in lymphoedema of the limbs. , 2009, The Cochrane database of systematic reviews.

[64]  R. Bush,et al.  Results of the national pilot screening program for venous disease by the American Venous Forum. , 2007, Journal of vascular surgery.

[65]  M. Godoy,et al.  Sensitivity and specificity of combined perimetric and volumetric evaluations in the diagnosis of arm lymphedema. , 2007, Prague medical report.

[66]  P. Lass,et al.  Lymphoedema: lymphoscintigraphy versus other diagnostic techniques--a clinician's point of view. , 2005, Nuclear medicine review. Central & Eastern Europe.

[67]  L. C. Jones,et al.  Bioelectrical impedance for monitoring the efficacy of lymphoedema treatment programmes , 2005, Breast Cancer Research and Treatment.

[68]  N. Liu,et al.  The role of magnetic resonance imaging in diagnosis of peripheral lymphatic disorders. , 1998, Lymphology.